Observing the safety of VYLOY in patients with gastric or GEJ cancer in South Korea
Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea
This study is testing how safe the drug VYLOY is for people in South Korea with advanced stomach or gastroesophageal junction cancer who are receiving it as part of their regular treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 377 (estimated) |
| Sex | All |
| Sponsor | Astellas Pharma Inc Industry-sponsored |
| Locations | 13 sites (Goyang-si, Gyeonggi-do and 12 other locations) |
| Trial ID | NCT06902545 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals in South Korea diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will receive VYLOY (zolbetuximab) as part of their standard treatment regimen, which is administered intravenously. The primary goal is to gather real-world data on the safety profile of VYLOY in this patient population, as well as to monitor the progression of their cancer over time.
Who should consider this trial
Good fit: Ideal candidates for this study are patients in South Korea with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma who are receiving VYLOY treatment.
Not a fit: Patients who have contraindications for VYLOY or are involved in other clinical trials with investigational drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of VYLOY for patients with gastric and GEJ cancers.
How similar studies have performed: Other studies have shown positive outcomes with similar treatments for gastric cancer, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who receive treatment with VYLOY injection, according to the approved local label. Exclusion Criteria: * Patients with any contraindication for VYLOY injection, according to the approved local label. * Patients who are registered or scheduled to be registered in any clinical trials involving investigational drug administration.
Where this trial is running
Goyang-si, Gyeonggi-do and 12 other locations
- Kr82010 — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
- Kr82008 — Suwon, Gyeonggi-do, South Korea (Recruiting)
- Kr82009 — Suwon, Gyeonggi-do, South Korea (Recruiting)
- Kr82006 — Yangsan, Gyeongsangnam-do, South Korea (Recruiting)
- Kr82012 — Hwasun Gun, Jeollanam-do, South Korea (Recruiting)
- Kr82001 — Seoul, South Korea (Recruiting)
- Kr82002 — Seoul, South Korea (Recruiting)
- Kr82003 — Seoul, South Korea (Recruiting)
- Kr82004 — Seoul, South Korea (Recruiting)
- Kr82005 — Seoul, South Korea (Recruiting)
- Kr82007 — Seoul, South Korea (Recruiting)
- Kr82011 — Seoul, South Korea (Recruiting)
- Kr82013 — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Astellas Pharma Global Development, Inc.
- Email: astellas.registration@astellas.com
- Phone: 800-888-7704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.